Our client provides navigation technology to reduce radiation exposure and improve accuracy.  They champion innovation for patients and caregivers alike to create a world where healthcare is safer and more accessible.  We are partnering with them to find a Systems Engineer to work alongside the development team to ensure product specifications are achieved and in compliance with medical regulatory practices and company procedures.

The Right Talent:

Bachelors Degree with 3+ years of medical device development experience.

Involvement with medical device regulatory standards such as IEC 60601, IEC 62304, ISO 14971 and ISO 13485 including experience with system risk/hazard analysis.

Experience with FDA 510(k) product/testing requirements. 

Excellent IT/computer skills and a willingness to learn new tools as they become relevant.